Advanced science.  Applied technology.

Program Management & Regulatory Submissions

Program Management & Regulatory Submissions

HOW CAN WE HELP YOU?

Projects can enter our pharmaceutical development pipeline at various stages of maturity. Our seasoned staff will quickly assess and determine gaps or high risk points for Chemistry Manufacturing and Control (CMC) and regulatory strategy in order to best advise our client.

Our project managers have direct experience advancing drugs from concept through Food and Drug Administration (FDA) licensure, setting up type 2 FDA meetings, preparing meeting packages, and identifying strategic questions that could impact development and lifecycle management costs. We have experience developing nonclinical safety and efficacy studies that will answer key development questions and expedite FDA review. We have experience writing, hyperlinking and submitting investigational new drugs (INDs) in electronic Common Technical Document (eCTD) format and submitting IND updates, even through phase 3 clinical studies.

Once under agreement, our project managers are empowered to execute the project, select specific staff with appropriate skills and authorize purchases to provide highly effective and efficient project teams to address our client’s requirements. The SwRI project manager has access to a full collection of robust enterprise-wide tools.

We understand that communication with our clients is critical. As such, the project manager will conduct frequent project updates with involved staff and contractors and provide reports to our clients describing progress, near-term issues and performance against budget. Potential disruptions to the project schedule are discussed with the project team, and then forwarded to our clients with recommendations for resolution.

Cost and schedule are tracked and reported to the client to ensure the viability of the program and to provide all required deliverables within the limits of the contract. SwRI uses real-time accounting methods to track project budgets and project deliverables. We also use earned value management systems (EVMS) as part of our project management strategy. Using EVMS, the impact of minor changes in schedule can be quantified in real time so that the budget impact – not only on the program element, but on the entire program – can be known in real time. Thus, budget risk and schedule risk are known when decisions are made. Using this system, the threshold of deviation can be agreed to with the client at the onset of the program so that everyone has the same level of certainty regarding the progress of the program.

We use online deliverables tracking internally and for its subcontractors to help manage on-time performance. Our multi-functional, integrated systems for project management result in project goals that are routinely met with minimum risk.

SwRI is an FDA-registered drug establishment (1614272) that supplies pharmaceuticals and drug products made under current Good Manufacturing Practices (cGMP) requirements. SwRI personnel can anticipate IND application requirements for all aspects of pharmaceutical development, so (where appropriate) data will be collected in anticipation of key elements and formats required for regulatory submission.